ファーマシューティカ アナリティカ アクタ

概要

Development and Validation of Spectrophotometric Methods for the Simultaneous Determination of Mebeverine Hydrochloride and Chlordiazepoxide in Bulk and in Dosage Form

Othman AA, El-Bagary RI, Elkady EF and El-Kerdawy MM

Two accurate, precise and simple spectrophotometric methods had been developed and validated for the determination of mebeverine hydrochloride (MEB) and chlordiazepoxide (CHL). The first method was used for the determination of MEB in the range of 5-81 μg/mL and CHL in the range of 0.5-4 μg/mL, MEB was determined by second derivative spectrophotometric determination by measuring the peak amplitude at 234.8 nm (zero value of CHL) whereas CHL was determined by first derivative spectrophotometric method by measuring the peak amplitude at 280.4 nm (zero value of MEB). In the second method, three chemometric methods were evaluated for simultaneous assay of MEB and CHL. The developed methods were successfully applied to the analysis of the cited drugs in laboratory prepared mixtures and tablets with good recoveries. The validity of the proposed methods was further assessed by applying the standard addition technique. The validation was carried out following the International Conference on Harmonization (ICH) guidelines.